Refractory Multiple Myeloma Clinical Trial
Official title:
Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
NCT number | NCT00002787 |
Other study ID # | 1104.00 |
Secondary ID | NCI-2012-00669 |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 1996 |
Verified date | May 2019 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
Status | Completed |
Enrollment | 22 |
Est. completion date | |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - ELIGIBILITY FOR VACCINE PREPARATION: - Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation - Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible - ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION: - Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera - Greater than 60 days post BMT - Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse - Stable absolute neutrophil count (ANC) > 1000 - Platelet count > 50,000 not requiring transfusions or growth factors - Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week - Treatment with a stable dose of Interferon is allowed - Karnofsky status > 60 percent - Immunosuppression: - Off all corticosteroids - Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only Exclusion Criteria: - Graft-vs-host disease requiring treatment with corticosteroids - Serum creatinine > 3.0 - Uncontrolled infection - Disease progression - Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol - Patients with a history of serious adverse reactions to GM-CSF - Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria | Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort. | Up to 2 years | |
Primary | Immune response | Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort. | Up to 2 years |
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